Study of Cognitive Reserve Disorder Affecting Depression in Aged Related Hearing Loss Via Rest State EEG

NCT05892731 | Unknown

• 1 other identifier: SYSKY-2023-424-01
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, patients with aged-related hearing loss with depression and without depression were evaluated by audiometry (pure tone audiometry and speech audiometry), cognitive function assessment (MMSE scale for simple mental state test, MoCA Scale for Montreal Cognitive Assessment), and depressive symptoms assessment (GDS-15 and HAMD), resting state EEG. The ananlysis of resting state EEG included power spectral density, traceability analysis, functional connectivity, microstate, clustering coefficient, characteristic path length, characteristic path permeability, and compatibility coefficient. EEG signals were used to explore the activation of brain regions and poor connectivity of brain regions affected by cognitive reserve dissonance on the level of brain imaging. This paper innovatively explores the influence of cognitive reserve dissonance on depressive mood in senile deafness by means of audiological assessment, cognitive function assessment, depression symptom assessment, resting state electroencephalography (EEG) and other technical means. Auditory and cognitive cortical activation, functional connectivity of brain regions, small-world attributes and microstates were analyzed in senile deafness with or without depression at the brain imaging level.

Conditions

Age-related Hearing Loss; Cognitive Decline; Depression

Outcome Measures

Primary Outcomes (2)

• score of Montreal Cognitive Assessment scale

  The Montreal Cognitive Assessment Scale(MoCA) is an assessment tool used to rapidly screen for cognitive abnormalities. The test included 11 tests in eight cognitive areas, including attention and concentration, executive function, memory, language, visual structure skills, abstract thinking, calculation, and orientation. Total score of 30 points, and the score of high school/technical secondary school or below needs to be added 1 point. Level: Normal 26-30 , mild cognitive impairment(MCI) 18-25, moderate cognitive impairment 10-17, severe cognitive impairment 0-9.

  1 day of enrollment

• score of Mini-mental State Examination

  Mini-mental State Examination (MMSE) is a scale for screening cognitive impairment and is widely used in dementia screening. The scale is divided into seven aspects, including time orientation, place orientation, immediate memory, attention and gauging, delayed memory, language and visual space. There are 30 items in the scale, with a total score of 30. The scale is 27 to 30 points normal, 21 to 26 points mild cognitive impairment, 10 to 20 points moderate cognitive impairment, and 0 to 9 points severe cognitive impairment.

  1 day of enrollment

Secondary Outcomes (5)

• pure tone average

  1 day of enrollment

• speech acceptance threshold

  1 day of enrollment

• Maximum speech recognition score

  1 day of enrollment

• score of 15-item Geriatric Depression Scale

  1 day of enrollment

• score of HAMD scale

  1 day of enrollment

Study Arms (2)

age-related hearing loss with depression

According to Hamilton depression scale, age-related hearing loss patients were divided into two groups, namely age-related hearing loss with depression and age-related hearing loss without depression.

Other: with depression

age-related hearing loss without depression

According to Hamilton depression scale, age-related hearing loss patients were divided into two groups, namely age-related hearing loss with depression and age-related hearing loss without depression.

Other: without depression

Interventions

with depression OTHER

age-related hearing loss with depression

age-related hearing loss with depression

without depression OTHER

age-related hearing loss without depression

age-related hearing loss without depression

Eligibility Criteria

• Age: 55 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In this study, PASS 15.0 was used to calculate the sample size, and the number of cases was arranged in a 1:1 ratio. The test efficacy was 1-β = 0.9, the test level was α = 0.05, σ=3.0. 17 cases were required in each group. Considering the 20% shedding rate, 22 cases were required in each group. Consequently, 44 cases of age-related hearing loss were included in this study.

You may qualify if:

• age ≥55 years, \< 90 years;
• For patients diagnosed with senile deafness, refering to Expert Consensus on Diagnosis and Intervention of Senile Hearing Loss, 2019 edition.
• mild, moderate, moderate and severe sensorineural hearing loss;
• Chinese who can cooperate with all Chinese version evaluation;
• right-handed;
• there was no middle ear disease or inner ear disease;
• there was no bilateral symmetry or sensorineural deafness;
• there was no severe neurological disease, serious systemic disease, family genetic history, or severe mental disease;
• there was no experience of hearing aids fitting.

You may not qualify if:

• pure tone audiometry suggests that the average pure tone hearing threshold (500Hz, 1kHz, 2kHz, 4kHz) is \> 91dB HL;
• sensorineural hearing loss caused by noise or drugs.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Presbycusis; Cognitive Dysfunction; Depression

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 7, 2023
• Study Start: February 8, 2023
• Primary Completion: April 16, 2023
• Study Completion: December 31, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)